CLB101 for Gut Health in Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new probiotic, CLB101™️, which could improve gut health for people with obesity. The probiotic aims to boost butyrate levels, a beneficial compound that can strengthen the gut lining and support immune health. The study compares CLB101™️ with a placebo (a substance with no active ingredients) to determine its effect on digestive issues like abdominal pain and bloating. Individuals with moderate to severe digestive symptoms and a BMI over 27 might be suitable candidates. Participants must avoid other probiotics during the study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on gut health and obesity.
Is there any evidence suggesting that CLB101™️ is likely to be safe for humans?
Studies have shown that CLB101 is generally safe for humans. A group of scientific experts has reviewed the research and granted this probiotic a self-affirmed GRAS (Generally Recognized as Safe) status, confirming its safety. CLB101 is also designed to produce butyrate, a natural substance in the gut that strengthens the gut lining and supports immune health.
Although specific side effects are not detailed, the GRAS status suggests that CLB101 is well-tolerated. This assurance is important for those considering joining a trial, as safety remains a top priority in its development.12345Why are researchers excited about this trial?
Unlike the standard treatments for obesity that often focus on diet, exercise, or medications to suppress appetite or block fat absorption, CLB101 is unique because it targets gut health directly. Researchers are excited about CLB101 because it introduces a novel approach by potentially altering gut microbiota, which may play a crucial role in managing obesity. By focusing on gut health, CLB101 could offer a new pathway to help people with obesity, potentially leading to more effective and sustainable weight management solutions.
What evidence suggests that CLB101™️ might be an effective treatment for gut health in obesity?
Research shows that CLB101, a new type of probiotic, produces butyrate directly in the gut. Butyrate strengthens the gut lining, supports the immune system, and maintains bacterial balance. Studies have found that probiotics producing butyrate can address digestive problems at their source. Additionally, probiotics like CLB101 may help reduce body weight, waist size, and body fat. These findings suggest that CLB101, which participants in this trial may receive, could improve gut health in people with obesity.16789
Who Is on the Research Team?
Naoh Craft, MD
Principal Investigator
People Science
Are You a Good Fit for This Trial?
This trial is for healthy, overweight individuals interested in improving their gut health. Participants should not have any gastrointestinal diseases or conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the study product CLB101TM or a placebo for 6 weeks to assess safety, tolerability, and impact on gut health
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CLB101™️
Trial Overview
The study tests CLB101™️, a probiotic designed to increase butyrate levels in the gut, which may strengthen the gut lining and support immune health. It's compared against a placebo in a randomized, double-blind setup.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Study group will receive the study product CLB101
Placebo control group will only receive the placebo until the end of study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ClostraBio Inc.
Lead Sponsor
Citations
A Randomized, Double-Blind, Placebo-Controlled Study ...
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of CLB101TM️ on Gut Health in Healthy, Overweight Individuals.
2.
ctv.veeva.com
ctv.veeva.com/study/a-randomized-double-blind-placebo-controlled-study-evaluating-the-impact-of-clb101tm-on-gut-healtA Randomized, Double-Blind, Placebo-Controlled Study ...
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of CLB101TM️ on Gut Health in Healthy, Overweight Individuals.
Impact of a Probiotic-Fiber Blend on Body Weight ...
The significant reductions in body weight, BMI, waist and hip circumference, and body fat percentage observed in the probiotic-fiber blend group ...
4.
linkedin.com
linkedin.com/posts/designs-for-health_designs-for-health-debuts-industry-first-activity-7379168945641213952-iPLoNew probiotic Anaerostipes Probiotic targets gut lining ...
Unlike traditional probiotics, Anaerostipes Probiotic is designed to address the root causes of digestive issues at the gut lining by ...
The Role of Probiotics in Modulating Gut Microbiota and ...
muciniphila have demonstrated significant potential in reducing visceral fat, improving glucose metabolism, and addressing obesity-related inflammation, making ...
ClostraBio Announces Key Milestones: Board Appointment ...
With validated safety data and GRAS designation, ClostraBio will introduce CLB101™ later this month in partnership with a leading health ...
7.
nutraingredients.com
nutraingredients.com/Article/2025/07/29/clostrabio-self-affirms-gras-status-for-next-gen-probiotic-ingredient-clb101/ClostraBio self-affirms GRAS status for next-gen probiotic ...
Shah said the GRAS affirmation of CLB101 demonstrates this strain is not only safe but can also be manufactured to meet specific quality ...
Product Solutions
CLB101™ has been granted self-affirmed GRAS (Generally Recognized as Safe) status by a panel of scientific experts. The GRAS designation follows rigorous review ...
9.
nutritionaloutlook.com
nutritionaloutlook.com/view/probiotic-strain-with-direct-butyrate-production-launched-in-north-american-marketProbiotic strain with direct butyrate production launched in ...
CLB101, a butyrate-producing probiotic, supports gut health by enhancing the intestinal lining, microbiome diversity, and immune balance.
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